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The One Voice Mission: A Quality Opus

I have worked within and around the life sciences community of Quality professionals for more years than I am ready to admit in a public post. Early on in my career, I listened avidly to every experienced person that I worked with, eager to take in everything anyone had to teach me. I was the quintessential eager beaver.When I look back, I realize that I was convinced that every word had a very particular meaning, that all aspects of this profession were black and white, and that all I need do, was pay close attention, respect my elders, and take it all in. I was a fast learner, a dedicated listener, and as enthusiastic as they came. Surely I would move ahead quickly, there could be no doubt that I was a bright shining star, just waiting to rise.I knew I had a lot to learn, but it turns out that very little of what I had to learn was technical in nature, or founded in clear and governing regulations.What I had to learn, and what I have learned, is that Quality is one of the grayest areas in not only the life science industry, but in any manufacturing environment.

At this point in my career, when I find myself dispensing advice to the newest rising stars, I begin with, “Quality is in the eye of the beholder, it may mean different things to different people at different times.”

An operations manager may consider the measure of Quality to be output vs. waste

A black belt may tell you that quality is a philosophy of improvement

A QC laboratory manager may tell you that Quality is a measure of material

A supply chain manager may tell you that Quality is a measure of service

A CEO could just as easily tell you that achieving Quality means building a stable and sustainable organization

In the face of that diversity, there are some things that I find to be consistently true:

Very few people would tell you that Quality is unimportant

Most people believe that they have either achieved Quality, or that they have the systems in place to ensure that they soon will

No measure of Quality can be realized unless all of the decision makers support the systems designed to assure it

As I learned those lessons, I came to believe that my primary goal was to help my clients define their vision of Quality, in order to help them achieve it. My mantra is “seek first to understand.” Seek to understand the objectives of the organization, the perspective point of the decision makers, and the needs of the client.

If there were an Olympic Gold for active listening, I would have that wrapped up.

I have worked with executives of multi-national organizations, private owners of small businesses, and every one in between. I have worked with companies that were just starting, companies trying to remediate known issues, companies responding to profound growth, companies in the midst of mergers, companies experiencing atypical demand and companies that were functioning under federal enforcement measures.

No matter the size of the company, the nature of their need or the type of their products, there is one critical commonality, one single component that must always exist in order to ensure Quality: the support of leadership.

Gaining support of the leadership is not as difficult as it sounds. Leaders are generally very practical people. They determine goals from a very high level, then they delegate to others who plan strategies, develop tactics, and eventually execute the tactical plans. At the highest organizational levels, the steps toward Quality can be as simple as defining objectives.

Simple at this level, usually means relevant and measurable.

Having the ability to access this organizational level, provides us the ability to define simple and relevant objectives before anyone attempts to develop or modify complex systems. Quality Systems are interactive; Their value diminishes significantly when they are taken one at a time. In order to develop multiple systems that can be efficiently executed at the operational level they must work together. In order for them to work together they must have been developed with the widest view possible.

Once objectives are clearly defined, the next step is to begin to define the mechanisms that can be used in tandem to control a variety of measurable areas of the business. Once the scope of mechanisms needed is clearly defined, we can go one step further and define the processes required to implement each of these mechanisms.

Each time we progress another step down this road, we also move another step down the corporate hierarchy. Each time we do that, we get closer to the resources that have a working knowledge of the day to day realities of production. And as we begin to involve those people, we begin to refine and provide detail to each individual process.

Building a system, or systems, that successfully address and control the diversity of interests that represent Quality, can be done; As long as we begin at the beginning, preserve our focus from concept to delivery, and have the right conversations, with the right people, at the right points in time.

As a community who should all be aspiring to the highest level of Quality that we can possibly achieve, we must resist the urge to allow the diversity in view points to result in a divergent, confusing, and discordant group of processes and procedures that are not relevant to each other, or to the high level objectives.

We must recognize that although we all provide a different service to the industry, all of our services exist within the industry for a reason, because they all matter.

output vs. waste matters

continual improvement matters

properties of material and product matters

reliable and timely service matters

stability and sustainability matters

Speaking of Quality individually, we can sound like a million voices, singing different songs, in different languages. If our Quality systems are developed individually, they will never be in harmony.

We may be a group of unique voices, each with different interests, characteristics, tempos and tones. But, if the interests of all of those voices are led by well orchestrated systems that understand our relationship, each to the other, we can achieve a perfect harmony.

Quality can be our Opus.

Let’s make that our mission.

Authored By:

Gina Guido-Redden Chief Operating Officer Coda Corp USA (p) 716.638.4180[email protected]https://www.codacorpusa.com.previewdns.com/“Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives.”